FDA NME & NCE

FDA NME & NCE

Start Up, New Molecular Entities (NME) and New Chemical Entities (NCE) are high quality, affordable products that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective and consistent compilation of NME & NCE Product and Process Development for…

FDA CDER & CBER Global Data Standards

FDA CDER & CBER Global Data Standards

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective and consistent use and application of Data Standards can reduce costs of…

Visible Particles within Injectable Products

Visible Particles within Injectable Products

The FDA expects and requires that Sterile Injectable Products adhere to strict FDA standards pertaining to quality, purity, safety, and efficacy. As a result, Patients and Physicians rely upon and trust that the Injectable Products they administer adhere to the same high standards. The cGMP Injectable Product Manufacturing process is generally the primary place where…

Pharmaceutical Product Development

Optimization of Pharmaceutical Dosage/ Formulation Chemistry

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. It involves designing, analyzing, and controlling manufacturing by taking timely measurements to ensure final product quality, efficacy, and safety. Pharmaceutical Product…

FDA Combination Products

Importance of FDA Combination Products

Introduction FDA (can also be expanded as the Food and Drug Administration) is a bureau that administers the public’s welfare by controlling and surveillance of food products, medications, vaccines, medical devices, etc. There are certain rules and criteria for post marketing safety reporting of FDA combination products. What are combination products? As per FDA’s guidelines,…